Engineer II - QA - SC

NCSL International; South Carolina; On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Annual Bonus

Matching 401(k) Retirement Plan

Free Onsite Clinics

Paid Time Off

Job summary

Arthrex, Inc. in Pendleton, SC is seeking an Engineer II for Quality Assurance to support lifecycle development of medical devices. You will work with cross-functional teams to ensure design and process quality, run audits, and lead CAPA actions.

The role requires a Bachelor's in Engineering and 2 years in QA/QC, with strong knowledge of design controls, GD&T, and process validation. Onsite manufacturing campus with competitive benefits.

Qualifications

• Bachelor's degree in Engineering required.
• Minimum 2 years in Quality Control/QA roles.
• Experience in medical devices preferred.

Responsibilities

• Review design drawings for tolerance and quality.
• Collaborate with suppliers to improve quality and validate processes.
• Assist in training QC inspectors on techniques and equipment.
• Participate in internal and external quality audits.
• Lead or support FMEA and risk assessments.
• Execute IQ/OQ/PQ validations and CAPA investigations.
• Manage NCRs; trend nonconformances and drive actions.
• Support environmental monitoring and continuous improvement.

Skills

QA/Quality Assurance

Statistical analysis

Process improvement

Design Controls

GD&T

Communication

Project management

Education

Bachelor's degree in Engineering

Tools

Excel

Word

Minitab

SAP

Pilgrim QMS

Job description

Requisition ID:

67747

Title:

Engineer II - QA - SC

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. We are currently seeking an Engineer II for Quality Assurance on our Pendleton, SC manufacturing campus. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Main Objective:

Responsible for supporting the Quality Manager with all quality related support for the life cycle development of Class I, II and III medical devices, including new product development and maintenance of released products.

Essential Duties and Responsibilities:

• Review design drawings for tolerance, inspect-ability and quality of design issues.
• Work with suppliers to improve quality, and assist, where necessary, in supplier process validations.
• Assist in the training of QC Inspectors on inspection techniques and the use of new equipment.
• Participate in Internal and External quality audits as directed by the Quality Assurance Manager.
• Support Risk Management by leading or participating in cross-functional team pFMEA's and Risk Assessments.
• Support the AMI Engineering Change Management process by performing tasks as assigned.
• Lead or Support the internal manufacturing First Article Inspection process, review First Article Inspection Reports and samples (internal and/or supplier).
• Lead or Support equipment or process validation (IQ, OQ, PQ)
• Lead or support Metrology with design and development of inspection methods and gages.
• Create or review inspection method work instructions.
• Lead or support Metrology with Measurement System Analysis (Gage R&R) studies.
• Create Inspection Plans Supporting Receiving and In-Process Inspection.
• Investigate complaints as requested by the Complaints/Reliability team.
• Lead completion of Nonconformances (NCR's) as assigned: material disposition plans, evaluations, and action plans.
• Perform routine Nonconformance and process trending and lead periodic Quality review meetings with the management team.
• Lead or Support Continuous Improvement projects.
• Lead or support the Environmental Monitoring program.
• Complete Root Cause Analysis Investigations and define Corrective/Preventive Action Plans (CAPA's).
• Perform Engineering Studies and Design of Experiments (DOE) as needed.
• Other duties as assigned.

Education and Experience:

• Bachelor's degree in Engineering required.
• 2 years experience in a Quality Control or Quality Assurance position required, medical device company preferred.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Technical knowledge in development methodologies including: Design Controls, GD&T, DOE, Process Verification and Validation.
• SPC (Statistical Process Control) knowledge.
• Working knowledge of process improvement tools (i.e.: Lean - PDCA, Six Sigma - DMAIC) and problem solving (i.e.: Kepner Tregoe, Lean A3, 5 Whys) preferred.
• Working knowledge of risk assessments, PFMEAs, control plans, quality plans.
• Strong communication skills and ability to communicate effectively with technical and non-technical staff.
• Project management skills preferred.

Machine, Tools, and/or Equipment Skills:

• Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), miniTab or similar statistical analysis software, SAP or similar inventory software, Agile or similar design lifecycle software, Pilgrim or similar QMS software.
• Knowledge of measurement and other inspection equipment.
• Manufacturing process knowledge

Arthrex Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.